MAUDE Adverse Event Report: COSMAN MEDICAL NITINOL TC ELECTRODE; ELECTRODES

Model Number TCN-10

Device Problem Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved: model#: tcn-10, lot #: 121716, description: nitinol tc electrode, 100 mm quantity: 3.

Event Description

Device analysis of the returned electrodes showed that there was a dark discoloration in the epoxy of all the electrodes.The color of a newly cured epoxy is amber/light brown.If the epoxy is subjected to too many autoclave cycles, the epoxy becomes brittle and discolored.The electrodes functioned despite the discoloration.

• Brand Name: NITINOL TC ELECTRODE
• Type of Device: ELECTRODES
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 6726188
• MDR Text Key: 80494333
• Report Number: 3006630150-2017-02548
• Device Sequence Number: 1
• Product Code: GXI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: TCN-10
• Device Lot Number: 113016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1